United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2002_register executive 2010-09-27 article Rules and Regulations D09002ee1c818847e D09002ee1c8188573 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) is announcing that it has issued an order in the form of a letter to Ethicon, Inc., reclassifying the absorbable polydioxanone surgical (PDS) suture intended for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery, from class III (premarket approval) to class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document entitled "Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA," which is immediately in effect as the special control for the PDS suture, but remains subject to public comment and possible future revision under the agency's good guidance practices. The agency is reclassifying this device into class II because new information supplied by the petitioner indicates that special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device, and there is sufficient information to establish special controls. Accordingly, the order is being codified in the Code of Federal Regulations. Any firm submitting a premarket notification (510(k)) for a new PDS suture will need to address the issues covered in the special control guidance. However, the firm need only show that its device meets the recommendations of the guidance or in some other way provides equivalent assurances of safety and effectiveness. 67 FR 77675 https://www.govinfo.gov/app/details/FR-2002-12-19/02-31993 02-31993 fr19de02-6 4160-01-S Docket No. 99P-5589 https://www.govinfo.gov/app/details/FR-2002-12-19/02-31993 https://www.govinfo.gov/content/pkg/FR-2002-12-19/html/02-31993.htm https://www.govinfo.gov/content/pkg/FR-2002-12-19/pdf/02-31993.pdf 3 p. 77675 77677 67 FR 77675 Title 21 Part 878 21 CFR Part 878 Medical Devices; Reclassification and Codification of the Absorbable Polydioxanone Surgical Suture; Federal Register Vol. 67, Issue RULE 02-31993 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2003-01-21 Docket No. 99P-5589 4160-01-S 02-31993 Final rule.

The Food and Drug Administration (FDA) is announcing that it has issued an order in the form of a letter to Ethicon, Inc., reclassifying the absorbable polydioxanone surgical (PDS) suture intended for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery, from class III (premarket approval) to class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document entitled "Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA," which is immediately in effect as the special control for the PDS suture, but remains subject to public comment and possible future revision under the agency's good guidance practices. The agency is reclassifying this device into class II because new information supplied by the petitioner indicates that special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device, and there is sufficient information to establish special controls. Accordingly, the order is being codified in the Code of Federal Regulations. Any firm submitting a premarket notification (510(k)) for a new PDS suture will need to address the issues covered in the special control guidance. However, the firm need only show that its device meets the recommendations of the guidance or in some other way provides equivalent assurances of safety and effectiveness.

This rule is effective January 21, 2003. The reclassification was effective September 4, 2001. Anthony D. Watson, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-3090. Medical devices: General and plastic surgery devices Absorbable polydioxanone surgical suture; reclassification and codification, http://www.fda.gov/cdrh http://www.fda.gov/cdrh/guidance.html Vol. 67, no. 244 Office of the Federal Register, National Archives and Records Administration 2002-12-19 continuing daily deposited born digital 274 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2002-12-19 P0b002ee180a97e20 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr19de02 https://www.govinfo.gov/app/details/FR-2002-12-19 https://www.govinfo.gov/content/pkg/FR-2002-12-19/pdf/FR-2002-12-19.pdf https://www.govinfo.gov/content/pkg/FR-2002-12-19/xml/FR-2002-12-19.xml fdlp 77645 77906 DGPO 2010-09-27 2024-06-07 FR-2002-12-19 machine generated eng FR FR-2002-12-19 67 244